Protocol summary

Summary
The present study has been designed to investigate the effect of PSO supplementation on lipid profiles of hyperlipidemic subjects. The study has a randomized, double-blind and placebo-controlled design. Sixty-six hyperlipidemic subjects (serum cholesterol > 200 mg/dl and serum triglycerides > 150 mg/dl) are to be recruited from an endocrine clinic using a sequential clinical trial design and randomly assigned into groups, the PSO (n =33) and placebo (n =33) groups, for all of whom demographic data and medical history at baseline will be documented, and subjects will be given capsules containing either PSO or placebo for four weeks. The PSO group will consume PSO capsules, containing 400 mg PSO twice daily (800 mg PSO), while controls will take placebo capsules with the same dosage. Measurements of anthropometric indexes, body composition, blood pressure and physical activity, and 3 consecutive dietary recalls will be obtained at baseline and 4 weeks after supplementation. At baseline and after 4 weeks, medication and supplement use will be recorded in a questionnaire, and for biochemical measurements, after 12 to 14 hours overnight fasting, blood samples will be taken for biochemical analysis, including cholesterol, triglycerides, LDL-C, HDL-C, ox-LDL, insulin and of fasting plasma samples.

General information

Acronym
effect of pomegranate seed oil on hyperlipidemia
IRCT registration information
IRCT registration number: IRCT138711151640N1
Registration date: 2009-07-16, 1388/04/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-07-16, 1388/04/25
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C), Tehran, I.R. Iran 2-Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University (M.C), Tehran, I.R. Iran.
Expected recruitment start date
2008-10-01, 1387/07/10
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of pomegranate seed oil on hyperlipidemic subjects: a double-blind placebo-controlled clinical trial
Public title
pomegranate seed oil study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: serum cholesterol concentrations > 200 mg/dl , serum triglyceride concentration > 150 mg/dl, age more than 20 years, body mass index ≤ 35 kg/m2 Exclusion criteria: being pregnant or lactating, diagnosed allergy and liver dysfunction
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethical committee of Research Institute for Endocrine Sciences of Shahid Beheshti Universit
Street address
No 24, Parvaneh street, Yemen Ave., Velenjak
City
Tehran
Postal code
19395-4763
Approval date
2008-07-07, 1387/04/17
Ethics committee reference number
50963

Health conditions studied

1

Description of health condition studied
hyperlipidemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias

Primary outcomes

1

Description
lipid profile concentration
Timepoint
1 month
Method of measurement
biochemical measurements on blood sample

Secondary outcomes

1

Description
hyperlipidemia
Timepoint
1 month
Method of measurement
biochemical measurements on blood sample

Intervention groups

1

Description
Pomegranate seed oil capsule, containing 400 mg PSO, twice daily (800 mg PSO) for 4 weeks
Category
Treatment - Drugs

2

Description
Placebo capsule
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine and metabolism clinic, Erfan hospital
Full name of responsible person
Street address
Riazi Bakhshayesh street, Kaj square, Saadat-abad
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C)
Full name of responsible person
Dr. Parvin Mirmiran
Street address
No 24, Parvaneh street, Yemen Ave., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C)
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Pharmaceutical Sciences Research Center, Faculty of Pharmacy , Tehran University (M.C)
Full name of responsible person
Dr. Abbas Shafie - Dr. Mohammadreza Fazeli
Street address
Poorsina street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences Research Center, Faculty of Pharmacy , Tehran University (M.C)
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C)
Full name of responsible person
Dr. Parvin Mirmiran
Position
Director of nutrition unit / PhD in nutrition
Other areas of specialty/work
Street address
No 24, Parvaneh street, Yemen Ave., Velenjak
City
Teharn
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C)
Full name of responsible person
Dr. Parvin Mirmiran
Position
Director of nutrition unit / PhD in nutrition
Other areas of specialty/work
Street address
No 24, Parvaneh street, Yemen Ave., Velenjak
City
Teharn
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University (M.C)
Full name of responsible person
Dr. Parvin Mirmiran
Position
Director of nutrition unit / PhD in nutrition
Other areas of specialty/work
Street address
No 24, Parvaneh street, Yemen Ave., Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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